Screening Tests for Anal Cancer

(SWAN Trial)

Recruiting at 4 trial locations

Overseen By Daniela Solis

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Prior high resolution anoscopy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to screen for anal cancer in women with certain HPV-related genital diseases or cancers. The goal is to identify the best screening techniques for early detection of anal cancer. HIV-negative women who have had cervical, vaginal, or vulvar disease or cancer may qualify for this trial. Participants will undergo standard anal cancer screening, including anal cytology (cell studies), HPV testing, and high-resolution anoscopy (a detailed examination of the anal area). As an unphased trial, this study provides an opportunity to contribute to important research that could enhance early detection methods for anal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these screening methods are safe for anal cancer detection?

Research shows that the tests used in this trial, such as high-resolution anoscopy, are generally safe and well-tolerated. High-resolution anoscopy helps detect abnormal cells in the lining of the anus and rectum and is considered useful and acceptable for screening. Studies have shown that these screening methods rarely cause serious side effects. Most participants find the tests acceptable and manageable. Mild discomfort may occur during the procedure, but serious problems are rare. Overall, the safety of these screening tests is well understood, and they are commonly used in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores more comprehensive screening techniques for anal cancer, specifically targeting women with a history of HPV. Unlike standard screenings that might rely on a single method, this approach combines anal cytology, HPV testing, and high-resolution anoscopy. This multi-faceted approach could lead to earlier and more accurate detection of anal cancer, potentially improving outcomes by identifying issues before they develop into cancer. By integrating multiple diagnostic tools, this method aims to refine screening accuracy and enhance early intervention strategies.

What evidence suggests that these diagnostic tests are effective for anal cancer screening?

Research has shown that screening methods for anal cancer can be effective, especially for individuals at higher risk. In this trial, participants will undergo standard care for anal cancer screening, including Anal Pap tests, HPV testing, and high-resolution anoscopy. Anal Pap tests can identify suspicious areas that might require further examination. High-resolution anoscopy, a detailed examination of the anal canal, is crucial for detecting these abnormal areas. Regular screening is recommended for those at higher risk, such as women with a history of abnormal tissue growths in the lower genital area, to catch changes early. The American Society for Colposcopy and Cervical Pathology recommends annual screenings for those at increased risk. These tests can detect issues sooner, which is vital for early treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth Chiao, MD

Principal Investigator

M.D. Anderson Cancer Center

Ashish Deshmukh, PhD

Principal Investigator

Medical University of South Carolina

Keith Sigel, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for women under 45 years old who have had high-grade HPV-related diseases or non-metastatic cancers of the cervix, vagina, or vulva. They must be HIV-negative and treated within Mount Sinai Health System or Harris Health System in Houston. Participants need to understand English or Spanish.

Inclusion Criteria

I have had a high-grade HPV-related disease or non-spreading cancer in my genital area.

Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston

I am 35 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluation including anal cytology, HPV testing, and high resolution anoscopy

1 visit

1 visit (in-person)

Follow-up Evaluation

Participants undergo follow-up evaluations to determine the incidence of anal high-grade squamous intraepithelial lesions and new hrHPV infections

24 months

2 visits (in-person) at 12 and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic tests for anal cancer screening

Trial Overview The study is evaluating diagnostic tests used to screen for anal cancer precursors in women with a history of lower genital tract neoplasias and cancers but who do not have HIV.

How Is the Trial Designed?

Group I: Women With Prior HPV for Anal Neoplasia Experimental Treatment 1 Intervention

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

Diagnostic tests for anal cancer screening is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Anal Pap test for:

• Screening for anal cancer precursors in high-risk populations

Approved in European Union as Digital rectal exam for:

• Detection of anal cancer and anal dysplasia

Approved in Canada as Anoscopy for:

• Diagnosis and screening of anal cancer

Approved in United States as High resolution anoscopy (HRA) for:

• Detection and treatment of anal dysplasia and anal cancer

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

In a study of 91 high-risk patients undergoing high-resolution anoscopy (HRA), 30% were found to have high-grade dysplasia, highlighting the importance of screening in this population.

Patients presenting with anal pain or lesions were significantly more likely to have high-grade dysplasia, suggesting that these symptoms should prompt consideration for HRA screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Symptomatology in Anal Dysplasia. Hicks, CW., Wick, EC., Leeds, IL., et al.[2015]

High Resolution Anoscopy (HRA) is a screening method used to detect anal intraepithelial neoplasia (AIN), a precancerous condition that can lead to anal squamous cell carcinoma (ASCC), particularly in immunocompromised patients.

Current literature shows mixed results regarding the effectiveness of HRA in managing AIN, indicating a need for further randomized controlled trials to clarify its benefits compared to other screening techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia. Gudur, A., Shanmuganandamurthy, D., Szep, Z., et al.[2019]

High-resolution anoscopy (HRA) is currently used for screening and managing anal squamous dysplasia, particularly in HIV-positive populations where the incidence is highest, but there are no randomized controlled trials or established guidelines for its use.

The understanding of anal dysplasia has evolved from studies on cervical dysplasia, highlighting the importance of human papillomavirus (HPV) in its development and the need for effective screening methods like HRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of High-Resolution Anoscopy. Cho, SD., Groves, E., Lao, VV.[2020]

A study involving 404 patients undergoing high resolution anoscopy (HRA) found that the median pain score was low (2 out of 10), indicating that the procedure is generally well-tolerated, although women reported higher pain levels than men.

Despite some experiencing higher pain, 76% of patients rated their satisfaction with the care received as a perfect 10, and 98% of women and 99% of men expressed willingness to undergo future HRA examinations, suggesting strong acceptability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acceptability of high resolution anoscopy examination in patients attending a tertiary referral centre. De-Masi, A., Davis, E., Cuming, T., et al.[2018]

In a study of 103 patients undergoing high-resolution anoscopy (HRA), 41.7% of the biopsied anal lesions were found to be high-grade anal intraepithelial neoplasia (AIN), indicating a significant prevalence of serious lesions among those screened.

Certain morphological features, such as irregular epithelial patterns and acetic acid-induced whitening, were strongly associated with high-grade AIN, providing a positive predictive value of 68.6% to help guide biopsy decisions during HRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which lesions should be biopsied during high-resolution anoscopy? Prospective descriptive study of simple morphological criteria. Camus, M., Lesage, AC., Fléjou, JF., et al.[2015]

In a study of 13,552 people with HIV, the introduction of high-resolution anoscopy (HRA) screening showed a significant reduction in the incidence of anal cancer and advanced anal cancer from 2011-2012 compared to earlier years, suggesting potential benefits of the screening program.

While the individual history of screening did not show a statistically significant association with reduced anal cancer rates, the overall trends indicate that HRA screening may be effective in lowering cancer incidence in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of a High-Resolution Anoscopy-Based Anal Cancer Screening Program Among People With HIV Enrolled in an Integrated Health Care System. Barnell, GM., Merchant, M., Lam, JO., et al.[2020]

High-resolution anoscopy (HRA) is generally well tolerated among HIV-infected patients, with 91.7% of surveyed patients reporting acceptable pain levels and all expressing willingness to return for a repeat procedure.

Factors such as pre-existing anal conditions, smoking history, and being female were associated with lower acceptability of HRA, indicating that certain patient characteristics may influence their experience and likelihood of returning for follow-up screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of high-resolution anoscopy for anal cancer screening in HIV-infected patients. Lam, JO., Barnell, GM., Merchant, M., et al.[2019]

Citations

1. academic.oup.com academic.oup.com/cid/article/74/Supplement_2/S179/6567970

Anal Cancer Screening and Prevention: Summary of Evidence ... This article summarizes key questions, evidence, recommendations, and areas for further research for the screening, diagnosis, and prevention of anal cancer.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043148917300192

High-resolution anoscopy: Is it necessary in the ... In this review, we will examine the literature evaluating the use of high-resolution anoscopy and its role in the screening, surveillance, and treatment of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4724586/

Anal cancer and intraepithelial neoplasia screening: A review Anal Pap testing may be useful as a way of alerting HRA clinicians to more closely examine suspicious lesions for low- vs high-grade heterogeneity thereby ...

4. bhiva.org bhiva.org/file/633c0e6015602/The-Utility-of-Digital-Anal-Rectal-Examinations-in-a-Public-Health-Screening-Program-for-Anal-Cancer.pdf

The-Utility-of-Digital-Anal-Rectal-Examinations-in-a-Public- ... Objectives: There are no uniform screening recommendations for anal cancer. Medical practice guidelines are now available on the use of Digital. Anal Rectal ...

5. asccp.org asccp.org/Assets/6e8dcdcb-d093-42ef-97cd-70a8c30dbf3e/638641643094670000/asccp-practice-advisory-anal-cancer-screening-final-pdf

ASCCP Practice Advisory: Anal Cancer Screening In summary, providers caring for patients with elevated risk of anal cancer (lower genital tract dysplasia, HIV, etc.) should offer routine annual digital anal ...

6. dceg.cancer.gov dceg.cancer.gov/research/cancer-types/anus/anal-cancer-screening-study

Anal Cancer Screening Study - NCI The goal of the Anal Cancer Screening Study is to evaluate risk factors associated with anal disease stages and biomarkers for anal precancer screening.

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/anoscopy-high-resolution-anoscopy

Anoscopy and High-Resolution Anoscopy High-resolution anoscopy can help better identify abnormal cells in the lining of the anus and rectum. For this reason, it can be especially helpful in:.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7147422/

The Utility of Digital Anal Rectal Examinations in a Public ... Digital Anal Rectal Examination satisfies most, but not all, WHO criteria for detecting an outcome of early invasive anal cancer in subpopulations at high risk ...

9. hivguidelines.org hivguidelines.org/guideline/hiv-anal-cancer/

Screening for Anal Dysplasia and Cancer in Adults With HIV In the ANCHOR study, progression to anal cancer was significantly reduced in participants who received treatment for high-grade squamous ...

10. aetna.com aetna.com/cpb/medical/data/800_899/0808.html

High-Resolution Anoscopy - Medical Clinical Policy Bulletins Screening was considered to be highly acceptable by participants. The authors concluded that the high prevalence of high-risk-HPV and frequency of false ...